TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20

The Therapeutic Goods Administration (TGA) has taken strong action against alleged illegal import, manufacture, supply and advertising of therapeutic goods in Australia during 2019-20. During the year, 187 infringement notices were issued for alleged breaches of the therapeutic goods legislation, totalling almost $1.8 million.

In the same period, the TGA pursued civil court action against three companies, with the Federal Court of Australia ordering one company to pay the Commonwealth $10 million for breaches of therapeutic goods advertising requirements. A further five criminal matters were referred to the Commonwealth Department of Public Prosecution.

These actions are an important part of the TGA's work to protect Australian consumers.

Infringements related to COVID-19

Alleged breaches of the therapeutic goods legislation in relation to the novel coronavirus (COVID-19) resulted in 58 infringement notices totalling $0.549 million. These were issued to 14 companies and 4 individuals between 26 March 2020 and 30 June 2020.

Other infringements

A further 129 infringement notices totalling $1.242 million were also issued throughout the financial year. These infringement notices, to 13 companies and 7 individuals, were for a range of alleged breaches of the therapeutic goods legislation not related to COVID-19.

Further information about the infringement notices can be found in the TGA's compliance and enforcement hub.

Court and other compliance actions in 2019-20

During the year thirteen search warrants were executed in support of criminal matters.

Civil action against advertisers and suppliers in the Federal Court of Australia included:

• In July 2019, the Federal Court ordered a company to pay $10 million to the Commonwealth for breaches of the mandatory rules for the advertising of medicines, including the ban on advertising prescription-only medicines to the general public.
• In March 2020, the TGA commenced proceedings in the Federal Court against a company and its Director in relation to alleged advertising offences. The Federal Court granted an interim injunction in April 2020 to prevent the advertising of specific therapeutic goods by the company and its Director.
• In June 2020, the Federal Court made orders temporarily restraining a company and its Director from advertising and supplying goods containing certain potentially dangerous substances.

In May 2020, the TGA entered into an enforceable undertaking with a company relating to alleged unlawful advertising. The company has committed to certain court-enforceable actions to ensure ongoing compliance.

The role of the TGA

The TGA regulates medicines, medical devices and biologicals under the Therapeutic Goods Act 1989 (the Act) and related legislation. These laws provide a national framework for the regulation of therapeutic goods to ensure their safety, quality, efficacy, timely availability and responsible advertising for the Australian community. To achieve a higher level of compliance with the requirements, the TGA can use a range of compliance and enforcement tools, including issuing infringement notices and pursuing court action.

Reporting illegal activity helps protect Australians

The TGA investigates suspected illegal activity in relation to the import, export, manufacture, supply and advertising of therapeutic goods.

If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.

Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising. The TGA encourages people to report suspected non-compliant advertising via its advertising complaints form.